Label: ANTIBACTERIAL liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 14, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Triclosan 0.14%

  • Purpose

    Antibacterial

  • Uses

    For hand washing to decrease bacteria on the skin.

  • Warnings

    For external use only.

    • When using this product, avoid getting into eyes. If this happens, rinse thoroughly with water.

    • Keep out of reach of children.
    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • wet hands
    • pump into hands
    • lather vigorously
    • rinse and dry thoroughly
  • Inactive Ingredients

    Water, Cocoamidopropyl Betaine, Sodium Lauryl Ether Sulphate, Coconut Acid Diethanol Amide, PEG-40 Castor Oil, Sodium Chloride, Phenoxyethanol, Fragrance, Citric Acid, Ethylenediaminetetraacetic Acid Disodium Salt, PEG-600 Stearate, Red 4(C.I. 14700)

    DISTRIBUTED BY
    TOPCO ASSOCIATES LLC
    7711 GROSS POINT RD.
    SKOKIE, IL 60077
    MADE IN CHINA
    © TOPCO JPC1106

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Floral Bottle Label

    VALU TIME
    antibacterial
    Hand Soap
    FLORAL
    11.5 FL OZ (340mL)

    Principal Display Panel – Floral Bottle Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Herbal Bottle Label

    VALU TIME
    antibacterial
    Hand Soap
    HERBAL
    11.5 FL OZ (340mL)

    Principal Display Panel – Herbal Bottle Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Natural Bottle Label

    VALU TIME
    antibacterial
    Hand Soap
    NATURAL
    11.5 FL OZ (340mL)

    Principal Display Panel – Natural Bottle Label
  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL 
    antibacterial liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    triclosan (UNII: 4NM5039Y5X) (triclosan - UNII:4NM5039Y5X) triclosan0.476 mL  in 340 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)  
    sodium chloride (UNII: 451W47IQ8X)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76162-101-01340 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/01/2006
    ANTIBACTERIAL 
    antibacterial liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    triclosan (UNII: 4NM5039Y5X) (triclosan - UNII:4NM5039Y5X) triclosan0.476 mL  in 340 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)  
    sodium chloride (UNII: 451W47IQ8X)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76162-102-01340 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/01/2006
    ANTIBACTERIAL 
    antibacterial liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    triclosan (UNII: 4NM5039Y5X) (triclosan - UNII:4NM5039Y5X) triclosan0.476 mL  in 340 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)  
    sodium chloride (UNII: 451W47IQ8X)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76162-103-01340 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/01/2006
    Labeler - Topco Associates LLC (006935977)
    Establishment
    NameAddressID/FEIBusiness Operations
    BBC Group Limited421270060MANUFACTURE
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